EP4344738A3 - Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation - Google Patents
Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation Download PDFInfo
- Publication number
- EP4344738A3 EP4344738A3 EP23215091.2A EP23215091A EP4344738A3 EP 4344738 A3 EP4344738 A3 EP 4344738A3 EP 23215091 A EP23215091 A EP 23215091A EP 4344738 A3 EP4344738 A3 EP 4344738A3
- Authority
- EP
- European Patent Office
- Prior art keywords
- fusion proteins
- insulin
- long acting
- ultra
- acting insulin
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 102000037865 fusion proteins Human genes 0.000 title abstract 6
- 108020001507 fusion proteins Proteins 0.000 title abstract 6
- 238000000034 method Methods 0.000 title abstract 2
- 241000282465 Canis Species 0.000 abstract 2
- 241000282324 Felis Species 0.000 abstract 2
- 102000018071 Immunoglobulin Fc Fragments Human genes 0.000 abstract 2
- 108010091135 Immunoglobulin Fc Fragments Proteins 0.000 abstract 2
- 102000004877 Insulin Human genes 0.000 abstract 2
- 108090001061 Insulin Proteins 0.000 abstract 2
- 108090000765 processed proteins & peptides Proteins 0.000 abstract 2
- 206010012601 diabetes mellitus Diseases 0.000 abstract 1
- 229940079593 drug Drugs 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 238000001727 in vivo Methods 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 230000035772 mutation Effects 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 102000040430 polynucleotide Human genes 0.000 abstract 1
- 108091033319 polynucleotide Proteins 0.000 abstract 1
- 239000002157 polynucleotide Substances 0.000 abstract 1
- 241000894007 species Species 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/575—Hormones
- C07K14/62—Insulins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
- A61K47/65—Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
- A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
- A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
- A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
- C07H21/00—Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
- C07H21/04—Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with deoxyribosyl as saccharide radical
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2869—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against hormone receptors
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
- C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
- C12N15/62—DNA sequences coding for fusion proteins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Diabetes (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Endocrinology (AREA)
- Biophysics (AREA)
- Epidemiology (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- Dermatology (AREA)
- Gastroenterology & Hepatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Emergency Medicine (AREA)
- Toxicology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Engineering & Computer Science (AREA)
- Wood Science & Technology (AREA)
- Physics & Mathematics (AREA)
- Plant Pathology (AREA)
- Microbiology (AREA)
- Neurology (AREA)
- Analytical Chemistry (AREA)
Applications Claiming Priority (19)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201862692498P | 2018-06-29 | 2018-06-29 | |
US201862692507P | 2018-06-29 | 2018-06-29 | |
US201862693814P | 2018-07-03 | 2018-07-03 | |
US201862696645P | 2018-07-11 | 2018-07-11 | |
US201862698648P | 2018-07-16 | 2018-07-16 | |
US201862702167P | 2018-07-23 | 2018-07-23 | |
US201862719347P | 2018-08-17 | 2018-08-17 | |
US201862740735P | 2018-10-03 | 2018-10-03 | |
US201862743358P | 2018-10-09 | 2018-10-09 | |
US201862774682P | 2018-12-03 | 2018-12-03 | |
US201862781368P | 2018-12-18 | 2018-12-18 | |
US201862781378P | 2018-12-18 | 2018-12-18 | |
US201962824176P | 2019-03-26 | 2019-03-26 | |
US201962827809P | 2019-04-01 | 2019-04-01 | |
US201962837188P | 2019-04-22 | 2019-04-22 | |
PCT/US2019/040010 WO2020006529A1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
EP19826154.7A EP3655006B1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
EP22203969.5A EP4186920B1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
EP21207279.7A EP4011908B1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
Related Parent Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP19826154.7A Division EP3655006B1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
EP21207279.7A Division EP4011908B1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
EP22203969.5A Division EP4186920B1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
Publications (2)
Publication Number | Publication Date |
---|---|
EP4344738A2 EP4344738A2 (fr) | 2024-04-03 |
EP4344738A3 true EP4344738A3 (fr) | 2024-05-22 |
Family
ID=68985236
Family Applications (5)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP21207279.7A Active EP4011908B1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
EP21164434.9A Active EP3892628B1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
EP22203969.5A Active EP4186920B1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
EP23215091.2A Pending EP4344738A3 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
EP19826154.7A Active EP3655006B1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
Family Applications Before (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP21207279.7A Active EP4011908B1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
EP21164434.9A Active EP3892628B1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
EP22203969.5A Active EP4186920B1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP19826154.7A Active EP3655006B1 (fr) | 2018-06-29 | 2019-06-28 | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
Country Status (15)
Country | Link |
---|---|
US (8) | US10851147B2 (fr) |
EP (5) | EP4011908B1 (fr) |
JP (2) | JP7417277B2 (fr) |
KR (1) | KR20210029210A (fr) |
CN (1) | CN113038964A (fr) |
AU (1) | AU2019291945A1 (fr) |
BR (1) | BR112020026777A2 (fr) |
CA (1) | CA3104144A1 (fr) |
DK (4) | DK4011908T5 (fr) |
FI (2) | FI4186920T3 (fr) |
HR (4) | HRP20221418T1 (fr) |
HU (4) | HUE058005T2 (fr) |
LT (4) | LT4186920T (fr) |
SI (4) | SI4186920T1 (fr) |
WO (1) | WO2020006529A1 (fr) |
Families Citing this family (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2017371217B2 (en) | 2016-12-09 | 2020-03-19 | Akston Biosciences Corporation | Insulin-Fc fusions and methods of use |
DK4011908T5 (da) | 2018-06-29 | 2024-08-12 | Akston Biosciences Corp | Ultralangtidsvirkende insulin-FC-fusionsproteiner og fremgangsmåder til anvendelse deraf |
US11267862B2 (en) | 2018-06-29 | 2022-03-08 | Akston Biosciences Corporation | Ultra-long acting insulin-Fc fusion proteins and methods of use |
WO2021011827A1 (fr) * | 2019-07-16 | 2021-01-21 | Akston Biosciences Corporation | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
AU2020407365B2 (en) * | 2019-12-19 | 2023-09-21 | Akston Biosciences Corporation | Ultra-long acting insulin-Fc fusion proteins and methods of use |
US11186623B2 (en) | 2019-12-24 | 2021-11-30 | Akston Bioscience Corporation | Ultra-long acting insulin-Fc fusion proteins and methods of use |
EP3972987B1 (fr) | 2020-04-10 | 2023-06-07 | Akston Biosciences Corporation | Immunothérapie spécifique d'un antigène pour des protéines de fusion de covid-19 et procédés d'utilisation |
US11192930B2 (en) | 2020-04-10 | 2021-12-07 | Askton Bioscences Corporation | Ultra-long acting insulin-Fc fusion protein and methods of use |
US11198719B2 (en) | 2020-04-29 | 2021-12-14 | Akston Biosciences Corporation | Ultra-long acting insulin-Fc fusion protein and methods of use |
EP4230216A1 (fr) * | 2020-07-24 | 2023-08-23 | Jiangsu Gensciences Inc. | Protéine de fusion insuline-fc et son application |
AU2021401635A1 (en) * | 2020-12-14 | 2023-06-22 | Eli Lilly And Company | Methods of treating diabetes |
WO2023004406A2 (fr) | 2021-07-23 | 2023-01-26 | Akston Biosciences Corporation | Protéines de fusion insuline-fc et méthodes d'utilisation pour traiter le cancer |
WO2023064711A2 (fr) * | 2021-10-14 | 2023-04-20 | Akston Biosciences Corporation | Protéines de fusion insuline-fc à action ultra-longue et méthodes d'utilisation |
TW202339790A (zh) | 2021-11-15 | 2023-10-16 | 美商美國禮來大藥廠 | 可保存之調配物 |
TW202342552A (zh) * | 2022-03-16 | 2023-11-01 | 大陸商北京拓界生物醫藥科技有限公司 | 人胰島素類似物、其融合蛋白及醫藥用途 |
TW202417519A (zh) * | 2022-06-23 | 2024-05-01 | 法商賽諾菲公司 | 單鏈胰島素及其Fc接合物 |
Citations (8)
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WO2010117760A2 (fr) * | 2009-03-30 | 2010-10-14 | Boehringer Ingelheim International Gmbh | Protéines hybrides comprenant des portions fc d'anticorps canins |
CN103509118A (zh) * | 2012-06-15 | 2014-01-15 | 郭怀祖 | 胰岛素-Fc融合蛋白 |
WO2016044676A2 (fr) * | 2014-09-18 | 2016-03-24 | AskGene Pharma, Inc. | Nouveaux agonistes du récepteur de l'érythropoïétine de félins |
WO2016119023A1 (fr) * | 2015-01-29 | 2016-08-04 | Nexvet Australia Pty Ltd | Agents diagnostiques et thérapeutiques |
WO2016178905A1 (fr) * | 2015-05-07 | 2016-11-10 | Eli Lilly And Company | Protéines de fusion |
WO2018009921A1 (fr) * | 2016-07-08 | 2018-01-11 | AskGene Pharma, Inc. | Protéine de fusion comprenant de la leptine et procédés de production et d'utilisation associés |
WO2018073185A1 (fr) * | 2016-10-17 | 2018-04-26 | Vetoquinol Sa | Région constante modifiée d'un anticorps |
WO2018107117A1 (fr) * | 2016-12-09 | 2018-06-14 | Akston Biosciences Corporation | Fusions d'insuline-fc et méthodes d'utilisation |
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US20030040601A1 (en) | 2001-06-08 | 2003-02-27 | Ivan Diers | Method for making insulin precursors and insulin analog precursors |
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WO2010107520A1 (fr) | 2009-03-20 | 2010-09-23 | Smartcells, Inc. | Conjugués d'insulines non déposées solubles et leurs utilisations |
CN101891823B (zh) | 2010-06-11 | 2012-10-03 | 北京东方百泰生物科技有限公司 | 一种Exendin-4及其类似物融合蛋白 |
US9074015B2 (en) * | 2010-07-28 | 2015-07-07 | Smartcells, Inc. | Recombinantly expressed insulin polypeptides and uses thereof |
AU2011282977A1 (en) | 2010-07-28 | 2013-02-21 | Smartcells, Inc. | Drug-ligand conjugates, synthesis thereof, and intermediates thereto |
AR087433A1 (es) | 2011-08-08 | 2014-03-26 | Merck Sharp & Dohme | Analogos de insulina n-glicosilados |
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EP3781147A4 (fr) | 2018-04-16 | 2022-04-20 | University of Utah Research Foundation | Insuline sensible au glucose |
DK4011908T5 (da) | 2018-06-29 | 2024-08-12 | Akston Biosciences Corp | Ultralangtidsvirkende insulin-FC-fusionsproteiner og fremgangsmåder til anvendelse deraf |
US11267862B2 (en) | 2018-06-29 | 2022-03-08 | Akston Biosciences Corporation | Ultra-long acting insulin-Fc fusion proteins and methods of use |
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JP2022507627A (ja) | 2018-11-19 | 2022-01-18 | ケース ウェスタン リザーブ ユニバーシティ | ポリ-アラニンc-ドメインのサブセグメントを有する単鎖インスリンアナログ |
CA3139946A1 (fr) | 2019-05-17 | 2020-11-26 | Case Western Reserve University | Analogues de l'insuline monocatenaire variante |
WO2021011827A1 (fr) | 2019-07-16 | 2021-01-21 | Akston Biosciences Corporation | Protéines de fusion insuline-fc à action ultra-longue et procédés d'utilisation |
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